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Data / FDA warning letters / 2024

FDA warning letters issued in 2024: 71 (from Nov 2024)

The full list. FDA warning letters issued in 2024: 71 rows for $5, FDA warning letters issued November 12, 2024 to October 30, 2026.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-warning-letters/year/2024, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated December 30, 2024. Source: FDA warning letters (U.S. Food and Drug Administration).

FDA issued 71 warning letters in 2024 from November 12, 2024 to December 30, 2024, to 71 companies; 2 have a closeout letter. The newest, issued December 30, 2024 by the Center for Biologics Evaluation and Research, went to Evolutionary Biologics Inc. (Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)).

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Letters
71
With closeout
2
Latest issued
December 30, 2024

Newest letters

The newest 71 of 71 by issue date, each linked to the letter on fda.gov.

IssuedCompanyIssuing officeSubjectPostedSource
December 30, 2024Evolutionary Biologics Inc.Center for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)January 28, 2025fda.gov
December 26, 2024Kingdom Creamery of Vermont LLCHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedJune 3, 2025fda.gov
December 26, 2024Reunipeche SASHuman Foods ProgramSeafood HACCP/CGMP for Foods/AdulteratedMay 27, 2025fda.gov
December 26, 2024Baldwin Richardson Foods Pennsauken, LLCHuman Foods ProgramLow Acid Canned Food Regulation/AdulteratedMay 21, 2025fda.gov
December 23, 2024Rey de los Camarones S. A.Human Foods ProgramSeafood HACCP/CGMP for Foods/AdulteratedMay 27, 2025fda.gov
December 23, 2024Nyumbani Hakuna Matata LLCDivision of Northern Border ImportsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsJanuary 21, 2025fda.gov
December 23, 2024By George Food Specialties Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)January 14, 2025fda.gov
December 23, 2024Guangzhou Sinocon Food Co., LtdHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedDecember 31, 2024fda.gov
December 20, 2024Golden Grains BakeryHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedMay 27, 2025fda.gov
December 19, 2024Fagron Compounding Services, LLC dba Fagron Sterile ServiceCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsFebruary 4, 2025fda.gov
December 19, 2024Integra LifeSciences CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 14, 2025fda.gov
December 19, 2024Viatris, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 24, 2024fda.gov
December 19, 2024JBRANDS LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Premium Fresh Growers LLCDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)January 21, 2025fda.gov
December 18, 2024COFISA - Conservas de Peixe da Figueira, S.A.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsJanuary 21, 2025fda.gov
December 18, 2024Hologic, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedJanuary 14, 2025fda.gov
December 18, 2024Bhargava Phytolab Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceutical/API/AdulteratedDecember 31, 2024fda.gov
December 18, 2024Sombra Cosmetics, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 24, 2024fda.gov
December 18, 2024E-liquid Brands, LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 20, 2024fda.gov
December 18, 2024Vapezilla LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Vape ManiaCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024SJ Trading LTD d/b/a Cloud Chasers ClubCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Shindler Distribution Inc. d/b/a VapoRushCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Jai Guruji LLC d/b/a Vape MarleyCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Elite VapesCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024DK Global Enterprises LLC d/b/a I Love Vape LLC / Matrix Wholesaler LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 18, 2024Chris Brown VapesCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 19, 2024fda.gov
December 17, 2024Right Value Drug Stores, LLC dba Carie Boyd PharmaceuticalsCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsMarch 11, 2025fda.gov
December 17, 2024Loyd Sanabria Hernandez dba Avicola Santa FeHuman Foods ProgramPHS Act/Shell Egg Regulation/AdulteratedDecember 24, 2024fda.gov
December 17, 2024Brands International CorporationCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow InspectionDecember 24, 2024fda.gov
December 17, 2024Anne’s Daye Ltd dba Tampon InnovationsCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceDecember 24, 2024fda.gov
December 17, 2024Akron Formulations India Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceutical/AdulteratedDecember 24, 2024fda.gov
December 16, 2024Skye Biologics Holdings LLCCenter for Biologics Evaluation and ResearchDeviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)May 20, 2025fda.gov
December 16, 2024Indoco Remedies LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJanuary 7, 2025fda.gov
December 12, 2024INCELL Corporation LLCCenter for Biologics Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedJanuary 21, 2025fda.gov
December 12, 2024XO Biologix, LLCCenter for Biologics Evaluation and ResearchUnapproved New Drugs/AdulteratedJanuary 7, 2025fda.gov
December 10, 2024Xcel Research LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 17, 2024fda.gov
December 10, 2024VeronvyCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 17, 2024fda.gov
December 10, 2024SwisschemsCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 17, 2024fda.gov
December 10, 2024Summit Research PeptidesCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 17, 2024fda.gov
December 10, 2024Prime Vitality, Inc. dba Prime PeptidesCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedDecember 17, 2024fda.gov
December 9, 2024Xoran Technologies, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedJanuary 14, 2025fda.gov
December 9, 2024Phillips Precision, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 14, 2025fda.gov
December 9, 2024MVRB2, LLC, d/b/a Kure CBD & VapeCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedDecember 9, 2024fda.gov
December 6, 2024Randox Laboratories LimitedCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedJanuary 14, 2025fda.gov
December 4, 2024Candymar Produce IncDivision of Southwest ImportsForeign Supplier Verification Program (FSVP)January 7, 2025fda.gov
December 3, 2024Micro Orgo ChemCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedDecember 17, 2024fda.gov
December 3, 2024Han C. Phan, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorDecember 3, 2024fda.gov
December 3, 2024Applied Therapeutics, Inc.Center for Drug Evaluation and ResearchSponsorDecember 3, 2024fda.gov
November 26, 2024Duong Ha Processing Trading Seafood Company LimitedHuman Foods ProgramSeafood HACCP/CGMP for Foods/AdulteratedJanuary 21, 2025fda.gov
November 22, 2024Becton, Dickinson, and Company/CareFusion 303, Inc.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedDecember 17, 2024fda.gov
November 22, 2024Mid America Pet Food LLCCenter for Veterinary MedicineCGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedDecember 10, 2024fda.gov
November 22, 2024Argon Medical Productions & Vertrieb Gesellschaft MBH & COCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated/MisbrandedOctober 29, 2024fda.gov
November 21, 2024Dr. Brite, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 10, 2024fda.gov
November 21, 2024LCC Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/MisbrandedDecember 3, 2024fda.gov
November 21, 2024Catwalk Cosmetic Laboratories Pty Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 26, 2024fda.gov
November 20, 2024Eurosirel S.P.ACenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 26, 2024fda.gov
November 18, 2024Breadbox Co.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsMay 20, 2025fda.gov
November 18, 2024Stew Leonard’s Holdings LLCHuman Foods ProgramFood Labeling/MisbrandedNovember 26, 2024fda.gov
November 18, 2024Hangzhou Huiji Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 26, 2024fda.gov
November 15, 2024Centura Pharmaceuticals IncCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded/OTCNovember 26, 2024fda.gov
November 14, 2024Salt City Baking Company, LLCHuman Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedJanuary 21, 2025fda.gov
November 13, 2024Western Innovations, Inc.Human Foods ProgramCGMP/Dietary Supplement/AdulteratedJanuary 21, 2025fda.gov
November 13, 2024Guangzhou Four E’s Scientific Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 10, 2024fda.gov
November 12, 2024Veterinary Select Formula dba Allergic PetCenter for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024Nutrition Strength Ltd.Center for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024Intermarket Industries Inc. dba Doc Ackerman Pet ProductsCenter for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024HDFrenchies LLC dba Bully BaumCenter for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024Evolution Pets LLCCenter for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024Energetic Essences, LLC dba Pet EssencesCenter for Veterinary MedicineNew Animal Drug/AdulteratedJanuary 7, 2025fda.gov
November 12, 2024Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedDecember 3, 2024fda.gov

By subject group

Subject groupLettersLatest
Food safety16December 26, 2024
Drug manufacturing (CGMP)16December 19, 2024
Tobacco products11December 19, 2024
Medical devices8December 19, 2024
Animal drugs and feed7November 22, 2024
Unapproved drugs, marketing and online sales6December 12, 2024
Biologics, cells and tissue2December 30, 2024
Drug compounding2December 19, 2024
Clinical research and labs2December 3, 2024
Dietary supplements1November 13, 2024

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research24December 19, 2024
Human Foods Program13December 26, 2024
Center for Tobacco Products11December 19, 2024
Center for Devices and Radiological Health8December 19, 2024
Center for Veterinary Medicine7November 22, 2024
Center for Biologics Evaluation and Research4December 30, 2024
Division of Northern Border Imports2December 23, 2024
Division of Southwest Imports2December 18, 2024

Where FDA publishes its warning letters

Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.